This Phase II clinical study investigates the safety and effectiveness of a new drug, Isomyosamine, in patients with sarcopenia or frailty, conditions associated with aging and muscle weakness. Isomyosamine is a promising oral medication that reduces inflammation by targeting cytokines like TNF-α and IL-6, which are linked to these conditions. Previous studies have shown it is well-tolerated and may help improve muscle strength, mobility, and healing after hip fractures. This trial aims to determine its potential benefits in reducing inflammation and improving recovery in elderly patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Isomyosamine 250 mg capsules dosed 4 times daily
Placebo 250 mg capsule 4 times daily
Change in Short Physical Performance Battery (SPPB) Test in subjects treated with Isomyosamine or placebo
Time frame: From enrollment to the end of treatment at 90 days
4-meter walk test
Change in the time taken to walk 4 meters through 90 days dosing.
Time frame: From enrollment to the end of treatment at 90 days
6-minute walk test
Change in the distance walked in the 6-minute walk test (m) through 90 days dosing.
Time frame: From enrollment to the end of treatment at 90 days
Grip strength
Change in grip strength score over 90 day dosing.
Time frame: From enrollment to the end of treatment at 90 days
Effect on serum levels of biochemical markers of TNF activation
Time frame: From enrollment to the end of treatment at 90 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 in the Isomyosamine vs Placebo groups
Time frame: From enrollment to the end of treatment at 90 days
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